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Fda in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

Fda in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

Name: Fda in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies
Brand: Columbia University Press
SKU: 9780231171182
Price: 730.00 HKD
Availability: InStock
Author: Holly Fernandez Lynch; I. Glenn Cohen
ISBN: 9780231171182

Edited by Holly Fernandez Lynch · I. Glenn Cohen

Columbia University Press October 2015

Specifications

ISBN-13: 9780231171182
Publisher: Columbia University Press
Publication: October 2015
Format: Hardback
Jurisdiction: U.S. ? Countri(es) for reference only

Details

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection.

Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good.

The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals.

The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

Acknowledgments

Introduction, by Holly Fernandez Lynch and I. Glenn Cohen

1. Historical Themes and Developments at FDA Over the Past Fifty Years, by Peter Barton Hutt

Part 1. FDA in a Changing WorldIntroduction, by Holly Fernandez Lynch

2. A Global and Innovative Regulatory Environment for the U.S. FDA, by Howard Sklamberg and Jennifer Devine

3. FDA and the Rise of the Empowered Patient, by Lewis A. Grossman

4. After the FDA: A Twentieth-Century Agency in a Postmodern World, by Theodore W. Ruger

5. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007, by Barbara J. Evans

Part 2. Preserving Public Trust and Demanding AccountabilityIntroduction, by Christopher Robertson

6. Global Trends Toward Transparency in Participant-Level Clinical Trials Data, by Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer

7. Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties, by Genevieve Pham-Kanter

8. The Crime of Being in Charge: Executive Culpability and Collateral Consequences, by Katrice Bridges Copeland

9. Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health, by Patrick O'Leary

Part 3. Protecting the Public Within Constitutional LimitsIntroduction, by Glenn Cohen

10. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, by Aaron S. Kesselheim and Michelle M. Mello

11. The FDCA as the Test for Truth of Promotional Claims, by Christopher Robertson

12. Why FDA's Ban on Off-Label Promotion Violates the First Amendment: A Study in the Values of Commercial Speech Protection, by Coleen Klasmeier and Martin H. Redish

Part 4. Timing Is Everything: Balancing Access and UncertaintyIntroduction, by W. Nicholson Price II

13. Speed Versus Safety in Drug Development, by R. Alta Charo

14. Overcoming "Premarket Syndrome": Promoting Better Postmarket Surveillance in an Evolving Drug Development Context, by Shannon Gibson and Trudo Lemmens

15. FDA's Public Health Imperative: An Increased Role for Active Postmarket Analysis, by Efthimios Parasidis

Part 5. Old and New Issues in Drug RegulationIntroduction, by R. Alta Charo

16. The Drug Efficacy Study and Its Manifold Legacies, by Daniel Carpenter, Jeremy Greene, and Susan Moffitt

17. Drug Safety Communication: The Evolving Environment, by Geoffrey Levitt18. Innovation Policy Failures in the Manufacturing of Drugs, by W. Nicholson Price II

Part 6. Regulatory Exclusivities and the Regulation of Generic Drugs and BiosimilarsIntroduction, by Benjamin N. Roin19. From "Recycled Molecule" to Orphan Drug: Lessons from Makena, by Kate Greenwood20. FDA, Negotiated Rule Making, and Generics: A Proposal, by Marie Boyd21. The "Follow-On" Challenge: Statutory Exclusivities and Patent Dances, by Arti Rai22. FDA Regulation of Biosimilars, by Henry Grabowski and Erika Lietzan

Part 7. New Wine in Old Bottles: FDA's Role in Regulating New TechnologiesIntroduction, by Frances H. Miller

23. Analog Agency in a Digital World, by Nathan Cortez

24. Twenty-First-Century Technology with Twentieth-Century Baggage: FDA Regulation of Regenerative Medicine, by Margaret Foster Riley

25. Device-ive Maneuvers: FDA's Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing, by Elizabeth R. Pike and Kayte Spector-Bagdady

26. A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records, by Andrew English, David Rosenberg, and Huaou Yan

27. Race and the FDA, by Jonathan KahnContributors

Index

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